# K213675: MP Reconstruction System

- Pathway: 510(k) (Special)
- Applicant: Waldemar Link GmbH & Co. KG
- Decided: Apr 11, 2022 after 140 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K955296 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142187: Link MP Reconstruction Prosthesis, Waldemar Link GmbH & Co. KG (2014) Summary page 4.
- K151008: Link® Megasystem-C®, Waldemar Link GmbH & Co. KG (2015) Summary page 4.

## Indications for use
The MP Reconstruction System is intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur. The MP Reconstruction System is indicated for the following conditions: 1. Revision arthroplasty due to juxta-articular bone defects. 2. Revision of loosened femoral prosthesis components involving extensive bone resorption of the proximal femur and widening of the medullary cavity or marked thinning of proximal femoral cortical bone. 3. Revision of loosened femoral prosthesis components by peri-/subprosthetic fracture. 4. Deformed proximal femur due to fractures or osteotomies. 5. Correction of bone deficiencies, e.g. due to tumors. 6. Large post-revision and post-trauma segmental bone defects. The MP Reconstruction System is for cementless use. Only cemented labeled modular stems are indicated for cemented use.

Source page: https://510kreport.com/device/K213675
Methodology: https://510kreport.com/methodology